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| |  ADA CONFERENCE: Avandia Lowers Blood Sugar In Type II Diabetes CHICAGO, IL -- June l5, 1998 -- SmithKline Beecham’s investigational oral diabetes drug Avandia® (rosiglitazone maleate) produces clinically and statistically-significant lowering of blood sugar in type II diabetes patients, according to a study presented today at the annual meeting of the American Diabetes Association’s 58th annual scientific sessions. Blood sugar control is recognised by the ADA as the cornerstone for managing diabetes and preventing serious complications. In the multi-centre, placebo-controlled, phase III clinical trial, rosiglitazone 8 mg/day when used alone reduced blood sugar levels by up to 76 milligrams, per decilitre (mg/dL) compared to the placebo group. "This 76 mg/dL drop in blood sugar levels is impressive. In trials of this type, it is rare to see a reduction in blood sugar levels greater than 60 mg/dL with any single drug," explained Barry Goldstein, M.D., rosiglitazone study group investigator and director of the division of endocrinology, diabetes and metabolic diseases, department of medicine, Jefferson Medical College, Philadelphia, PA. "Rosiglitazone's ability to improve blood sugar control may help patients better manage their disease. Improved control may delay or prevent some of the long-term complications of diabetes, such as blindness or kidney disease." Diabetes mellitus is a chronic disease characterised by high blood sugar levels that result from defects in the body's ability to use and/or produce insulin. It can lead to blindness, heart disease, kidney failure and limb amputation. There are two main types of diabetes: type I and type II. People with type I diabetes are usually diagnosed when they are children or young adults. The pancreas of a person with type I diabetes makes little or no insulin and these patients must inject insulin every day to live. Most people with diabetes have type II, in which the pancreas keeps making insulin for some time, but the body can't use it very well. Eventually, many patients with type II diabetes will require insulin injections. Rosiglitazone directly targets insulin resistance -- an underlying condition responsible for type II diabetes -- and is a member of a new class of diabetes agents called thiazolidinediones (TZDs), insulin sensitivity enhancers. In contrast to traditional type II diabetes medicines, which increase insulin production in the pancreas or decrease glucose output through the liver, rosiglitazone reduces the amount of insulin needed while improving glycemic control. In other studies, rosiglitazone has also been shown to have no clinically significant drug interactions with acarbose, digoxin, metformin, ranitidine, warfarin and cytochrome P450-metabolized drugs, such as nifedipine and one of the most commonly prescribed oral contraceptives. The 26-week study included 493 patients, most of whom were receiving another oral diabetes drug at the time of study entry. Study participants were assigned to one of three groups: placebo, rosiglitazone 8 mg/day or rosiglitazone 4 mg/day. The study included periodic measurements of blood sugar and hemoglobin A1c (HbA1c) levels, which reflect average amounts of blood sugar over the preceding two to three months and are directly related to the risks of long-term complications. Compared to placebo, blood sugar levels were reduced by up to 76 mg/dL in the group receiving the highest dose of rosiglitazone (8 mg/day). Results for the group receiving the lower dose (4 mg/day) demonstrated a 58 mg/dL reduction in blood sugar levels. The effectiveness of rosiglitazone was further confirmed by measurement of HbA1c levels. In the study, HbA1c levels were reduced by 1.54 percent and 1.21 percent of total hemoglobin in the 8 mg/day and 4 mg/day dose, respectively. "It is very exciting that we may soon have a new treatment option for type II diabetes," Dr. Goldstein said. "This treatment alternative -- which helps the body more effectively use its natural insulin -- may assist patients in managing their disease." "This is a statistically and clinically significant drop in blood sugar levels and may help patients meet the ADA treatment goals for blood sugar control," said James Gavin, M.D., past ADA president and senior scientific officer of the Howard Hughes Medical Institute, Chevy Chase, MD. "Both patients and physicians recognise the importance of meeting the ADA goals, however, this has been difficult with current single-agent treatment regimens." Rosiglitazone was well tolerated. Overall, reported side effects occurred at similar frequencies in the placebo group and the rosiglitazone treatment groups. The most common adverse events reported in both groups included upper respiratory tract infections and headache. As is common practice, patients in the clinical trial were routinely tested for blood enzyme elevations that might suggest liver damage. Of the nearly 5,500 type II diabetes patients enrolled in these trials, approximately 2,500 received rosiglitazone for a minimum of six months, with 1,400 receiving the drug for more than one year. "In the study, rosiglitazone appeared to be free of clinically significant liver side effects," said Harold Lebovitz, M.D., rosiglitazone study group investigator, and professor of medicine, chief, endocrinology and metabolism/diabetes and director of the Diabetes, Diagnostic and Treatment Center at State University of New York Health Science Center in Brooklyn. "This could potentially eliminate the need to perform costly and routine liver function tests on patients, if additional and continuing studies do not show evidence of any significant liver toxicity."
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